Summary:
Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with the Practice Manager, the laboratory failed to report all positive SARS-CoV-2 test results as required for 2 of 5 patients that tested positive since the laboratory started testing for SARS-COV-2 on August 17, 2022. Findings include: 1. An interview on 10/11/2022 at 12:00 pm with the Practice Manager revealed the laboratory started testing August 17, 2022. 2. A review of a narrative, the laboratory revealed two patients had tested positive by the laboratory for SARS-CoV-2 and the laboratory lacked the documentation to show the positive results were sent to the health department. 3. A review of the laboratory's "COVID-19: Patient Care, Charting, and Reporting Policy and Procedure" revealed a section stating, "It is the policy of the center that all positive test results will be reported to the Kent County Health Department, only including demographic data." 4. The surveyor requested documentation of the laboratory's attempts to report the 2 positive SARS-CoV-2 results using its SARS-CoV-2 antigen test systems to the health department on 10/11/22 at 12:10 pm and it was not made available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --